Dual modality energy delivery system

ABSTRACT

An economical dual modality system can be manufactured and used in a method including the steps of assembling a system including a durable energy subsystem and a replaceable thermal subsystem, activating the replaceable thermal subsystem, attaching the system to a desired treatment area of a user&#39;s body, and activating the durable energy subsystem. The durable energy subsystem is arranged and configured to deliver energy, and the replaceable thermal subsystem is arranged and configured to be coupled to the durable energy subsystem arranged and configured to deliver thermal energy. The replaceable thermal subsystem delivers thermal energy to the desired treatment area at a predetermined temperature range for at least 30 minutes, and the durable energy subsystem delivers energy from the group consisting of non-visible light electromagnetic radiation, visible light radiation, electromagnetic field, microcurrent, electrical stimulation, iontophoresis, sonophoresis and combinations thereof independently of the thermal energy.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. provisional application62/553,167 filed on Sep. 1, 2017.

FIELD OF THE INVENTION

The present invention generally relates to a system which utilizes lighttherapy in the treatment of musculoskeletal pain, reduction of edema andinflammation, and promoting the healing of tissues, especially softtissues like muscle, tendons, and ligaments. More specifically, theinvention relates to a system with a durable energy subsystem, areplaceable thermal subsystem, and a means to couple the durable energysubsystem and the replaceable thermal subsystem to a desired treatmentarea of a user's body.

BACKGROUND OF THE INVENTION

Light, when delivered to the body, has been shown to elicit a wide rangeof therapeutic effects. Specifically, light can be used as a therapeuticagent for various disorders. For example, light therapy devices havebeen used for treatment of musculoskeletal pain.

Examples of light emitters used in light therapy may include lasers andlight emitting diodes (LEDs). LEDs are often preferred for having theability to illuminate a larger area than a laser. Light emitted fromLEDs may decrease wrinkles and skin roughness by increasing collagen andelastin synthesis, and reduce pigmentation in human skin. Furthermore,the emitted light may protect against subsequent photo damage, preventpost-inflammatory hyperpigmentation and reduce scar formation duringhealing. Also, the illumination from blue, red, or infrared LEDs maycause generation and release of nitric oxide, which may subsequentlylead to pain relief.

Light therapy is often delivered in a doctor's office in light chambersthat deliver light to the entire body surface. The amount of lightdelivered is based on the amount of time the patient is exposed to lightand the intensity of the light. The light is delivered to the entirebody even though the region that requires treatment often composes afraction of the overall surface area of the body. When receiving thismodality of light therapy, the patient must wear protective eyewear toprevent exposure of light to the eyes. If the patient is exposed to morelight than intended, cellular damage and/or burns may occur over a largeportion of the body, leading to significant discomfort and even medicaltreatment. So typically, a trained professional is required to deliverthe light to ensure that the patient receives the correct dose of lightand that sensitive areas, such as the eyes, are not exposed to thelight.

For home use, focused light devices have been developed. Focused lightsolves the issue of light exposure to areas that do not need therapybecause the user directs the light to the area where the therapy isneeded. A disadvantage of some known therapeutic device is that it isinconvenient for the user to hold the device in position for an extendedperiod of time. This is particularly true if the area to be treated isdifficult to reach, such as the user's back or feet. In this regard, itwould be desirable to provide a device that would be more convenientlyheld in position for an extended period of time without requiring theuser to hold it.

Typically, the light therapy device includes a rigid housing having anapplicator end. The applicator end is integrally attached to the housingthus forming a self-contained unit. Light emitting diodes (“LEDs”) arepositioned in the housing such that they emit light from the applicatorend of the device. The housing generally also contains a battery packand a processor for controlling the frequency and duration of lightdelivery. Other electrical components may be provided in the housingdepending on the electronic features of the device.

To operate the known therapeutic device, a user grasps the rigid housingof the device and positions the applicator end of the device on the areato be treated. The LEDs are then energized causing light radiation atthe applicator end of the device. For effective treatment, the radiationmust be applied for a specified time period. This requires the device tobe held in place by the user. Depending on the area and problem that istreated, the duration of the treatment can vary from a few minutes toseveral hours.

A further disadvantage of the known devices is that, depending on thearea treated, once the device is strapped, a user can no longer see thecontrol display. For example, if the user straps the unit to his back,he can no longer see the face of the housing and will be unable tomonitor the display. Furthermore, to change a setting, the user will berequired to unstrap the device to access the control panel, and thenre-strap the unit once the setting has been changed. It would bedesirable, to provide a unit that could comfortably be applied to thearea for treatment while allowing the user convenient access to thecontrol panel.

The application of thermal energy (heat or cold) is also known astherapies to treat aches, bruises, pains, sprains, and strains. Thecombination of light and thermal energy is also desired for thetreatment of pain and promoting the healing of tissues. Devices thatcombine both forms of energy may be able to bring greater relief to theuser. Portable devices that deliver both light and thermal energy haveissues with the required power to run both energy sources. Bulkybatteries, or the need to plug into an electric outlet, hinder theconvenience desired in a combination device. So, a device with a durablelight emitter and a replaceable thermal energy source is desirable.

Cold and heat packs, such as gel-based packs, are widely used for firstaid. Cold packs may be used to reduce swelling or to help recover fromthe sun. The gel inside the gel packs is provided to store cold/warmthsuch that a target area can be slowly cooled or heated during therapy.Typically, the gel packs are provided with a flexible package materialsuch that the pack may be formed and applied to uneven target treatmentareas such as limbs, faces, joints, etc. Often, the gel packs arereusable, and may be reheated in, for example a microwave oven, orre-cooled in a freezer. A disadvantage of these is the user may apply anoverheated or overcooled gel-pack to the site of pain, potentiallycausing more harm to the site of pain.

In summary, there is a need for improved wearable devices deliveringphototherapy and thermal therapy that are comfortable, easy to operateand allow for relief from musculoskeletal pain and other ailments(including injury to bones, joints, muscles, tendons, ligaments, ornerves) without requiring long treatment durations or a visit to aphysician's office.

SUMMARY OF THE INVENTION

Surprisingly, we have found that an economical dual modality system canbe manufactured and used in a method including the steps of assembling asystem including a durable energy subsystem and a replaceable thermalsubsystem, activating the replaceable thermal subsystem, attaching thesystem to a desired treatment area of a user's body, and activating thedurable energy subsystem. The durable energy subsystem is arranged andconfigured to deliver energy, and the replaceable thermal subsystem isarranged and configured to be coupled to the durable energy subsystemarranged and configured to deliver thermal energy. The replaceablethermal subsystem delivers thermal energy to the desired treatment areaat a predetermined temperature range for at least 30 minutes, and thedurable energy subsystem delivers energy from the group consisting ofnon-visible light electromagnetic radiation, visible light radiation,electromagnetic field, microcurrent, electrical stimulation,iontophoresis, sonophoresis and combinations thereof independently ofthe thermal energy.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded view of an embodiment of a dual modality system ofthe present invention;

FIG. 2 is a top perspective view of the dual modality system embodimentof FIG. 1;

FIG. 3 is a cross-sectional view of the of the embodiment of FIG. 2 inthe x-z plane;

FIG. 4 is a bottom perspective view of the embodiment of FIG. 1;

FIG. 5 is an exploded view of a second embodiment of a dual modalitysystem of the present invention;

FIG. 6 is a top perspective view of the dual modality system embodimentof FIG. 5;

FIG. 7 is a cross-sectional view of the of the embodiment of FIG. 6 inthe x-z plane;

FIG. 8 is a bottom perspective view of the embodiment of FIG. 5;

FIG. 9 is an exploded view of a third embodiment of a dual modalitysystem of the present invention;

FIG. 10 is a top perspective view of the dual modality system embodimentof FIG. 9;

FIG. 11 is a cross-sectional view of the of the embodiment of FIG. 10 inthe x-z plane;

FIG. 12 is a bottom perspective view of the embodiment of FIG. 9;

FIG. 13 is an exploded view of a fourth embodiment of a dual modalitysystem of the present invention;

FIG. 14 is a top perspective view of the dual modality system embodimentof FIG. 13;

FIG. 15 is a cross-sectional view of the of the embodiment of FIG. 14 inthe x-z plane;

FIG. 16 is a bottom perspective view of the embodiment of FIG. 13;

FIG. 17 is an exploded view of a fifth embodiment of a dual modalitysystem of the present invention;

FIG. 18 is a top perspective view of the dual modality system embodimentof FIG. 17;

FIG. 19 is a cross-sectional view of the of the embodiment of FIG. 18 inthe x-z plane;

FIG. 20 is a bottom perspective view of the embodiment of FIG. 17;

FIG. 21 is a top perspective view of a first embodiment of a durableenergy subsystem of the present invention;

FIG. 22 is a bottom perspective view of the durable energy subsystemembodiment of FIG. 21;

FIG. 23 is a top perspective view of a second embodiment of a durableenergy subsystem of the present invention;

FIG. 24 is a bottom perspective view of the durable energy subsystemembodiment of FIG. 23;

FIG. 25 is a top perspective view of an embodiment of a durable energysubsystem of the present invention encased in a protective coating;

FIG. 26 is a bottom perspective view of the encased durable energysubsystem embodiment of FIG. 25;

FIG. 27 is an exploded view of a sixth embodiment of a dual modalitysystem of the present invention;

FIG. 28 is a top perspective view of the dual modality system embodimentof FIG. 27;

FIG. 29 is a cross-sectional view of the of the embodiment of FIG. 28 inthe x-z plane;

FIG. 30 is a bottom view of the embodiment of FIG. 27;

FIG. 31 is an exploded view of a seventh embodiment of a dual modalitysystem of the present invention;

FIG. 32 is a bottom perspective view of the belt or strap component ofthe seventh embodiment;

FIG. 33 is a top perspective view of the dual modality system embodimentof FIG. 31;

FIG. 34 is a top perspective view of a clip used in the seventhembodiment;

FIG. 35 is a top perspective view of the attachment means of the belt tothe durable energy subsystem chassis in the seventh embodiment prior toengagement; and

FIG. 36 is a top perspective view of the attachment means of the belt tothe durable energy subsystem chassis in the seventh embodiment whenengaged.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to a system to provide superior treatmentto an area of a user's body. The following description is presented toenable one of ordinary skill in the art to make and use the invention.Various modifications to the embodiments and the generic principles andfeatures described herein will be readily apparent to those skilled inthe art. Thus, the present invention is not intended to be limited tothe embodiments shown, but is to be accorded the widest scope consistentwith the features described herein.

The dual modality system described herein uses a durable energysubsystem, a replaceable thermal subsystem, and a means to couple thedurable energy subsystem and the replaceable thermal subsystem to adesired treatment area of a user's body. The energy from the dualmodality system may be delivered continuously or discontinuously, ordelivered intermittently (also called “pulsed”).

As used herein the specification and the claims, the term “topical” andvariants thereof mean of or applied to an isolated part of the body.This includes, without limitation skin, mucosa, and enamel.

The method for applying a desired treatment to an area of a user's bodyuses the herein system where the dual modality system is coupled to thedesired treatment area of a user's body, and a treatment cycle isinitiated.

FIGS. 1 to 4 show a first embodiment of a dual modality system 10 of thepresent invention. FIG. 1 is an exploded view of dual modality system 10which has a durable energy subsystem chassis 20 and a replaceablethermal subsystem 80.

Replaceable thermal subsystem 80 has a first surface 82, a secondsurface 84, and four side surfaces 86. In some embodiments, replaceablethermal subsystem 80 includes a heat source, while in other embodiments,replaceable thermal subsystem 80 includes a cooling source.

Durable energy subsystem chassis 20 has a main body 30 and end tabs 50.Main body 30 has a first longitudinal end 31, a second longitudinal end32, a first surface 33, a second surface 34, and a receptacle defined bybottom surface 36 and inner side surfaces 38. Disposed in or proximateto second surface 34 of main body 30 are a plurality of energy emitters70. End tabs 50 are preferably flexible and are disposed on firstlongitudinal end 31 and second longitudinal end 32. End tabs 50 each hasa first surface 52, and a second surface 54. In some embodiments,durable energy subsystem chassis 20 is flexible. Durable energysubsystem chassis 20 may optionally include at least one componentarranged and configured to communicate data through wired or wirelesscommunication with external devices, such as a smart phone or othercomputer or communication device connected to a network.

Replaceable thermal subsystem 80 is coupled to the durable energysubsystem chassis 20 and arranged and configured to deliver thermalenergy. FIGS. 2 and 4 are top and bottom, respectively, perspectiveviews of dual modality system 10 when the system is assembled. FIG. 3 isa cross-sectional view of dual modality system 10 in the x-z plane ofFIG. 2. When assembled, replaceable thermal subsystem 80 is disposed inreceptacle of main body 30 of durable energy subsystem chassis 20 sothat second surface 84 of replaceable thermal subsystem 80 at leastpartially contacts receptacle bottom surface 36, and side surfaces 86 ofsubsystem 80 at least partially contact receptacle inner side surfaces38. In some embodiments, replaceable thermal subsystem 80 is held inreceptacle of main body 30 of durable energy subsystem chassis 20 by afriction fit between side surfaces 86 of subsystem 80 and receptacleinner side surfaces 38. In other embodiments, an adhesive may be used tohold replaceable thermal subsystem 80 in receptacle of main body 30. Theadhesive may be located on any or all of second surface 84 or sidesurfaces 86 of replaceable thermal subsystem 80, or receptacle bottomsurface 36 or inner side surfaces 38. In still other embodiments,durable energy subsystem chassis 20 may be held in receptacle of mainbody 30 via snap fit, pins, dowels, or other known coupling features inreceptacle.

In this embodiment, replaceable thermal subsystem 80 is in the shape ofa rectangular prism, and the receptacle of main body 30 is shaped to fita rectangular prism.

As mentioned, end tabs 50 are disposed on first longitudinal end 31 andsecond longitudinal end 32. End tabs 50 may be integral to, or attachedto, main body 30 of durable energy subsystem chassis 20. Attachment maybe achieved using an adhesive or welding the end tabs 50 to main body30. In addition, although energy emitters 70 are shown as disposed in orproximate to second surface 34 of main body 30, energy emitters 70 maybe disposed on the surface of second surface 34 of main body 30. Theplurality of energy emitters 70 are disposed in an emission region ofthe chassis having a length and a width, wherein the emission regionlength and emission region width are both substantially greater than anemission region depth. Although FIG. 4 shows fifteen energy emitters 70,the number of energy emitters 70 in energy subsystem chassis 20 willdepend on the treatment type, intensity, and area being treated. Thenumber of energy emitters 70 could be 1, or 2, or 5, or 10, or 20, or50, or 100 or more.

Although FIG. 1 shows a regular array of energy emitters 70, thearrangement of these need not be a regular array. For example, one maydesire to concentrate active elements in certain portions of energysubsystem chassis 20 and reduce the frequency/density of energy emitters70 in other portions of energy subsystem chassis 20. In addition, energyemitters 70 may be placed around the periphery of energy subsystemchassis 20 and be coupled a wave guide that evenly distributes theenergy throughout the chassis.

Possible cross-sectional shapes of energy emitters 70 include, but arenot limited to, squares, rectangles, triangles, circles, ovals, kidneys,stars, crosses, characters, etc.

In use, durable energy subsystem chassis 20 and the replaceable thermalsubsystem 80 comprising dual modality system 10 are coupled to a desiredtreatment area of a user's body. In this embodiment, adhesive disposedon second surface 54 of end tabs 50 acts as a means to couple dualmodality system 10 to a desired treatment area of a user's body. In use,second surface 34 of main body 30 contacts the desired treatment area ofa user's body.

In other embodiments, adhesive may also be disposed on second surface 34of main body 30. In still other embodiments, end tabs 50 may not bepresent, and adhesive disposed on second surface 34 of main body 30 mayact as a means to couple dual modality system 10 to the desiredtreatment area of a user's body.

Optionally, first embodiment dual modality system 10 also has releasepaper disposed on the regions having adhesive. In use, the user wouldfirst dispose replaceable thermal subsystem 80 into receptacle of mainbody 30, remove any release paper covering regions having adhesive, andplace the dual modality system 10 on the desired treatment area of auser's body. In this embodiment, replaceable thermal subsystem 80 isintegrated with the means to couple durable energy subsystem chassis 20and replaceable thermal subsystem 80 to a desired treatment area of auser's body. Operational details of durable energy subsystem chassis 20will be discussed later in this document.

Though shown as rectangular in shape, dual modality system 10 may havevarious sizes and shapes depending on the location of use for system.Possible shapes of the footprint left by dual modality system 10include, but are not limited to, squares, rectangles, triangles,circles, ovals, kidneys, stars, crosses, characters, etc. The corners ofsuch shapes, if any, may be angular or curved to reduce potentiallift/removal points. The area of the treatment could be greater thanabout 1,000 cm², about 1,000 cm², or about 100 cm², or about 10 cm², orabout 1 cm², or less than 1 cm².

FIGS. 5 to 8 show a second embodiment of a dual modality system 100 ofthe present invention. FIG. 5 is an exploded view of dual modalitysystem 100 which has a durable energy subsystem chassis 120, areplaceable thermal subsystem 180, and a cover 160. Replaceable thermalsubsystem 180 has a first surface 182, a second surface 184, and fourside surfaces 186, and may be a heat source or a cooling source.

Durable energy subsystem chassis 120 has a main body 130 and end tabs150. Main body 130 has a first longitudinal end 131, a secondlongitudinal end 132, a first surface 133, a second surface 134, and areceptacle defined by bottom surface 136 and inner side surfaces 138.Disposed in or proximate to second surface 134 of main body 130 are aplurality of energy emitters 170. End tabs 150 are preferably flexibleand are disposed on first longitudinal end 131 and second longitudinalend 132. End tabs 150 each have a first surface 152, and a secondsurface 154. In some embodiments, durable energy subsystem chassis 120is flexible. Durable energy subsystem chassis 120 may optionally includeat least one component arranged and configured to communicate datathrough wired or wireless communication with external devices, such as asmart phone or other computer or communication device connected to anetwork.

Cover 160 has a first surface 162, a second surface 164, and a pluralityof apertures 166. Though cover 160 is shown as separate of energysubsystem chassis 120, in some embodiments it may be attached to mainbody 130 with pins or screws so that it may pivot between an open andshut position with respect to the receptacle of main body 130. In someembodiments, cover 160 may be attached to main body 130 via a livinghinge (a thin flexure bearing hinge) made from the same material as thetwo pieces it connects. Also, though this embodiment shows cover 160with a plurality of apertures 166, other embodiments may have coverswith no apertures. The plurality of apertures 166 may provide airpermeability or skin breathability to dual modality system 100.

Replaceable thermal subsystem 180 is coupled to the durable energysubsystem chassis 120 and arranged and configured to deliver thermalenergy. FIGS. 6 and 8 are top and bottom, respectively, perspectiveviews of dual modality system 100 when the system is assembled. FIG. 7is a cross-sectional view of dual modality system 100 in the x-z planeof FIG. 6. When assembled, replaceable thermal subsystem 180 is disposedin receptacle of main body 130 of durable energy subsystem chassis 120so that first surface 182 of replaceable thermal subsystem 180 may atleast partially contacts second surface 164 of cover 160, second surface184 of replaceable thermal subsystem 180 may at least partially contactsreceptacle bottom surface 136, and side surfaces 186 of subsystem 180may at least partially contact receptacle inner side surfaces 138.

In this embodiment, replaceable thermal subsystem 180 is held inreceptacle of main body 130 of durable energy subsystem chassis 120 bycover 160. Cover 160 may be held in a closed position by a snap fit orother known means, and couples replaceable thermal subsystem 180 in thereceptacle of main body 130. In other embodiments, an adhesive may beused to supplement cover 160. Since replaceable thermal subsystem 180 isheld in receptacle of main body 130 by cover 160, replaceable thermalsubsystem 180 may be smaller in volume that the volume of the receptacleof main body 130.

In this embodiment, replaceable thermal subsystem 180 is in the shape ofa rectangular prism. In other embodiments, replaceable thermal subsystem180 may be in other three-dimensional shapes.

End tabs 150, disposed on first longitudinal end 131 and secondlongitudinal end 132 of main body 130, may be integral to, or attachedto main body 130 of durable energy subsystem chassis 120. Attachment maybe achieved using an adhesive, or welding the end tabs 150 to main body130 if they are not formed as integral to main body 130 of durableenergy subsystem chassis 120. In addition, although energy emitters 170are shown as disposed in or proximate to second surface 134 of main body130, energy emitters 170 may be disposed on the surface of secondsurface 134 of main body 130. The plurality of energy emitters 170 aredisposed in an emission region of the chassis having a length and awidth, wherein the emission region length and emission region width areboth substantially greater than an emission region depth.

Although FIG. 8 shows fifteen energy emitters 170 in a regular array,the number and arrangement of energy emitters 170 in energy subsystemchassis 120 will depend on the treatment type, intensity, and area beingtreated.

In use, durable energy subsystem chassis 120 and the replaceable thermalsubsystem 180 comprising dual modality system 100 are coupled to adesired treatment area of a user's body. In this embodiment, adhesivedisposed on second surface 154 of end tabs 150 acts as a means to coupledual modality system 100 to a desired treatment area of a user's body.In use, second surface 134 of main body 130 contacts the desiredtreatment area of a user's body.

In other embodiments, adhesive may also be disposed on second surface134 of main body 130. In still other embodiments, end tabs 150 may notbe present, and adhesive disposed on second surface 134 of main body 130may act as a means to couple dual modality system 100 to the desiredtreatment area of a user's body.

Though not shown, second embodiment dual modality system 100 may alsohave release paper disposed on the regions having adhesive. In use, theuser would first dispose replaceable thermal subsystem 180 intoreceptacle of main body 130, attach cover 160 to main body 130, removeany release paper covering regions having adhesive, and place the dualmodality system 100 on the desired treatment area of a user's body. Inthis embodiment, replaceable thermal subsystem 180 is integrated withthe means to couple durable energy subsystem chassis 120 and replaceablethermal subsystem 180 to a desired treatment area of a user's body.Operational details of durable energy subsystem chassis 120 will bediscussed later in this document.

As discussed previously, dual modality system 100 may have various sizesand shapes depending on the location of use for system.

FIGS. 9 to 12 show a third embodiment of a dual modality system 200 ofthe present invention. FIG. 9 is an exploded view of dual modalitysystem 200 which has a durable energy subsystem chassis 220 and areplaceable thermal subsystem 280. Replaceable thermal subsystem 280 hasa first surface 282, a second surface 284, and four side surfaces 286,and may be a heat source or a cooling source.

Durable energy subsystem chassis 220 has a main body 230 and end tabs250. Main body 230 has a first longitudinal end 231, a secondlongitudinal end 232, a first surface 233, a second surface 234, aplurality of apertures 246, and a receptacle defined by bottom surface236, top surface 244, and three inner side surfaces 238. Slot 240replaces the fourth inner side surface. Disposed in or proximate tosecond surface 234 of main body 230 are a plurality of energy emitters270. End tabs 250 are preferably flexible and are disposed on firstlongitudinal end 231 and second longitudinal end 232. End tabs 250 eachhave a first surface 252, and a second surface 254. In some embodiments,durable energy subsystem chassis 220 is flexible. Durable energysubsystem chassis 220 may optionally include at least one componentarranged and configured to communicate data through wired or wirelesscommunication with external devices, such as a smart phone or othercomputer or communication device connected to a network.

Replaceable thermal subsystem 280 is coupled to the durable energysubsystem chassis 220 and arranged and configured to deliver thermalenergy. FIGS. 10 and 12 are top and bottom, respectively, perspectiveviews of dual modality system 200 when the system is assembled. FIG. 11is a cross-sectional view of dual modality system 200 in the x-z planeof FIG. 10. When assembled, replaceable thermal subsystem 280 isdisposed in the receptacle of main body 230 of durable energy subsystemchassis 220 so that first surface 282 of replaceable thermal subsystem280 may at least partially contact receptacle top surface 244, secondsurface 284 of replaceable thermal subsystem 280 may at least partiallycontact receptacle bottom surface 236, and three side surfaces 286 ofsubsystem 280 may at least partially contact three inner side surfaces238.

Replaceable thermal subsystem 280 is held in receptacle of main body 230of durable energy subsystem chassis 220 by any number of friction fits.These include friction fits between side surfaces 286 and receptacleinner side surfaces 238, between first surface 282 and top surface 244,or between second surface 284 and receptacle bottom surface 236. In someembodiments, an adhesive or other coupling feature may be used to holdreplaceable thermal subsystem 280 in receptacle of main body 230.

In this embodiment, replaceable thermal subsystem 280 is in the shape ofa rectangular prism. In other embodiments, replaceable thermal subsystem280 may be in other three-dimensional shapes.

End tabs 250, disposed on first longitudinal end 231 and secondlongitudinal end 232 of main body 230, may be integral to, or attachedto main body 230 of durable energy subsystem chassis 220. Attachment maybe achieved using an adhesive, or welding the end tabs 250 to main body230 if they are not formed as integral to main body 230 of durableenergy subsystem chassis 220.

In addition, though energy emitters 270 are shown as disposed in orproximate to second surface 234 of main body 230, energy emitters 270may be disposed on the surface of second surface 234 of main body 230.The number, shape and arrangement of energy emitters 270 in energysubsystem chassis 220 will depend on the treatment type, intensity, andarea being treated. The plurality of energy emitters 270 are disposed inan emission region of the chassis 220 having a length and a width,wherein the emission region length and emission region width are bothsubstantially greater than an emission region depth.

In use, durable energy subsystem chassis 220 and the replaceable thermalsubsystem 280 comprising dual modality system 200 are coupled to adesired treatment area of a user's body. In this embodiment, adhesivedisposed on second surface 254 of end tabs 250 acts as a means to coupledual modality system 200 to a desired treatment area of a user's body.In use, second surface 234 of main body 230 contacts the desiredtreatment area of a user's body.

In other embodiments, adhesive may also be disposed on second surface234 of main body 230. In still other embodiments, end tabs 250 may notbe present, and adhesive disposed on second surface 234 of main body 230may act as a means to couple dual modality system 200 to the desiredtreatment area of a user's body.

The plurality of apertures 246 disposed on main body 230 may provide airpermeability or breathability to dual modality system 200. In someembodiments, main body 230 does not have apertures. In otherembodiments, improved skin breathability may be achieved by main body230 having a discontinuous skin-contact surface.

Though not shown, third embodiment dual modality system 200 may haverelease paper disposed on the regions having adhesive. In use, the userwould first dispose replaceable thermal subsystem 280 into receptacle ofmain body 230 by sliding the subsystem through slot 240, remove anyrelease paper covering regions having adhesive, and place the dualmodality system 200 on the desired treatment area of a user's body. Inthis embodiment, replaceable thermal subsystem 280 is integrated withthe means to couple durable energy subsystem chassis 220 and replaceablethermal subsystem 280 to a desired treatment area of a user's body.Operational details of durable energy subsystem chassis 220 will bediscussed later in this document.

As discussed previously, dual modality system 200 may have various sizesand shapes depending on the location of use for system.

FIGS. 13 to 16 show a fourth embodiment of a dual modality system 300 ofthe present invention. FIG. 13 is an exploded view of dual modalitysystem 300 which has a durable energy subsystem chassis 320 and areplaceable thermal subsystem 380. Replaceable thermal subsystem 380 hasa first surface 382, a second surface 384, four side surfaces 386 andapertures 388, and may be a heat source or a cooling source.

Durable energy subsystem chassis 320 has a main body 330 and end tabs350. Main body 330 has a first longitudinal end 331, a secondlongitudinal end 332, a first surface 333, a second surface 334, aplurality of apertures 346, and a receptacle defined by bottom surface336 and four inner side surfaces 338. Disposed in first surface 333 ofmain body 330 are a plurality of energy emitters 370. End tabs 350 arepreferably flexible and are disposed on first longitudinal end 331 andsecond longitudinal end 332. End tabs 350 each have a first surface 352,and a second surface 354. In some embodiments, durable energy subsystemchassis 320 is flexible. Durable energy subsystem chassis 320 mayoptionally include at least one component arranged and configured tocommunicate data through wired or wireless communication with externaldevices, such as a smart phone or other computer or communication deviceconnected to a network.

Replaceable thermal subsystem 380 is coupled to the durable energysubsystem chassis 320 and arranged and configured to deliver thermalenergy. FIGS. 14 and 16 are top and bottom, respectively, perspectiveviews of dual modality system 300 when the system is assembled. FIG. 15is a cross-sectional view of dual modality system 300 in the x-z planeof FIG. 14. When assembled, replaceable thermal subsystem 380 isdisposed in the receptacle of main body 330 of durable energy subsystemchassis 320 so that first surface 382 of replaceable thermal subsystem380 may at least partially contact receptacle bottom surface 336, andfour side surfaces 386 of subsystem 380 may at least partially contactinner side surfaces 338. Apertures 388 of replaceable thermal subsystem380 are disposed in the receptacle of main body 330 of durable energysubsystem chassis 320 so that they are aligned with energy emitters 370of main body 330.

Replaceable thermal subsystem 380 is held in receptacle of main body 330of durable energy subsystem chassis 320 by any number of means. Theseinclude friction fits between side surfaces 386 and receptacle innerside surfaces 338, or between first surface 382 and receptacle bottomsurface 336. In some embodiments, an adhesive or other coupling featuremay be used to hold replaceable thermal subsystem 380 in receptacle ofmain body 330. In other embodiments, replaceable thermal subsystem 380is held in receptacle of main body 330 by being trapped betweenreceptacle bottom surface 336 and the treatment area of the user whendual modality system 300 is in contact with the treatment area of auser's body.

In this embodiment, replaceable thermal subsystem 380 is in the shape ofa rectangular prism. In other embodiments, replaceable thermal subsystem380 may be in other three-dimensional shapes.

End tabs 350, disposed on first longitudinal end 331 and secondlongitudinal end 332 of main body 330, may be integral to, or attachedto main body 330 of durable energy subsystem chassis 320. Attachment maybe achieved using an adhesive, or welding the end tabs 350 to main body330 if they are not formed as integral to main body 330 of durableenergy subsystem chassis 320.

In addition, though energy emitters 370 are shown as disposed in orproximate to second surface 334 of main body 330, energy emitters 370may be disposed on the surface of second surface 334 of main body 330.The number, shape and arrangement of energy emitters 370 in main body330 will depend on the treatment type, intensity, and area beingtreated. The plurality of energy emitters 370 are disposed in anemission region of the chassis 320 having a length and a width, whereinthe emission region length and emission region width are bothsubstantially greater than an emission region depth.

In use, durable energy subsystem chassis 320 and the replaceable thermalsubsystem 380 comprising dual modality system 300 are coupled to adesired treatment area of a user's body. In this embodiment, adhesivedisposed on second surface 354 of end tabs 350 acts as a means to coupledual modality system 300 to a desired treatment area of a user's body.In use, second surface 384 of replaceable thermal subsystem 380 contactsthe desired treatment area of a user's body.

In other embodiments, adhesive may also be disposed on second surface334 of main body 330. In still other embodiments, end tabs 350 may notbe present, and adhesive disposed on second surface 334 of main body 330may act as a means to couple dual modality system 300 to the desiredtreatment area of a user's body.

The plurality of apertures 346 disposed on main body 330. The pluralityof apertures 346 may provide air permeability or skin breathability todual modality system 300. In some embodiments, main body 330 does nothave apertures. In other embodiments, improved skin breathability may beachieved by main body 330 having a discontinuous skin-contact surface.

Though not shown, fourth embodiment dual modality system 300 may alsohave release paper disposed on the regions having adhesive. In use, theuser would first place replaceable thermal subsystem 380 into receptacleof main body 330, remove any release paper covering regions havingadhesive, and place the dual modality system 300 on the desiredtreatment area of a user's body. In this embodiment, replaceable thermalsubsystem 380 is integrated with the means to couple durable energysubsystem chassis 320 and replaceable thermal subsystem 380 to a desiredtreatment area of a user's body. Operational details of durable energysubsystem chassis 320 will be discussed later in this document.

As discussed previously, dual modality system 300 may have various sizesand shapes depending on the location of use for system.

FIGS. 17 to 20 show a fifth embodiment of a dual modality system 400 ofthe present invention. FIG. 17 is an exploded view of dual modalitysystem 400 which has a durable energy subsystem chassis 420, areplaceable thermal subsystem 480, and an adhesive band 450 to attachdurable subsystems 420 and replaceable thermal subsystem 480 to thedesired treatment area of a user's body. Replaceable thermal subsystem480 has a first surface 482, a second surface 484, and four sidesurfaces 486, and may be a heat source or a cooling source.

Durable energy subsystem chassis 420 has a body 430. Body 430 has afirst surface 433, a second surface 434, and a receptacle defined bybottom surface 436 and four inner side surfaces 438. Disposed in firstsurface 433 of body 430 are a plurality of energy emitters 470. In someembodiments, durable energy subsystem chassis 420 is flexible. Durableenergy subsystem chassis 420 may optionally include at least onecomponent arranged and configured to communicate data through wired orwireless communication with external devices, such as a smart phone orother computer or communication device connected to a network.

Adhesive band 450 has a first surface 452, and a second surface 454, andmay be a flexible web.

Replaceable thermal subsystem 480 is coupled to the durable energysubsystem chassis 420 and arranged and configured to deliver thermalenergy. FIGS. 18 and 20 are top and bottom, respectively, perspectiveviews of dual modality system 400 when the system is assembled. FIG. 19is a cross-sectional view of dual modality system 400 in the x-z planeof FIG. 18. When assembled, replaceable thermal subsystem 480 isdisposed in the receptacle of main body 430 of durable energy subsystemchassis 420 so that second surface 484 of replaceable thermal subsystem480 may at least partially contact receptacle bottom surface 436, andfour side surfaces 486 of subsystem 480 may at least partially contactinner side surfaces 438.

Replaceable thermal subsystem 480 is held in receptacle of main body 430of durable energy subsystem chassis 420 by any number of means. Theseinclude friction fits between side surfaces 486 and receptacle innerside surfaces 438. In other embodiments, an adhesive may be used to holdreplaceable thermal subsystem 480 in receptacle of main body 430. In yetother embodiments, replaceable thermal subsystem 480 is held inreceptacle of main body 430 by being trapped between receptacle bottomsurface 436 and the treatment area of the user when dual modality system400 is in contact with the treatment area of a user's body.

In this embodiment, replaceable thermal subsystem 480 is in the shape ofa rectangular prism. In other embodiments, replaceable thermal subsystem480 may be in other three-dimensional shapes.

In addition, though energy emitters 470 are shown as disposed in orproximate to second surface 434 of main body 430, energy emitters 470may be disposed on the surface of second surface 434 of main body 430.The number, shape and arrangement of energy emitters 470 in main body430 will depend on the treatment type, intensity, and area beingtreated. The plurality of energy emitters 470 are disposed in anemission region of the chassis 420 having a length and a width, whereinthe emission region length and emission region width are bothsubstantially greater than an emission region depth.

In use, durable energy subsystem chassis 420 and the replaceable thermalsubsystem 480 comprising dual modality system 400 are coupled to adesired treatment area of a user's body. In this embodiment, adhesivedisposed on second surface 454 of adhesive band 450 acts as a means tocouple dual modality system 400 to a desired treatment area of a user'sbody. In use, first surface 433 of main body 430 contacts the desiredtreatment area of a user's body. In some embodiments, adhesive may alsobe disposed on first surface 433 of main body 430. Second surface 454 ofadhesive band 450 contacts first surface 482 of replaceable thermalsubsystem 480, second surface 434 of main body 430, and the user's skin.

Though not shown, fifth embodiment dual modality system 400 may alsohave release paper disposed on the regions having adhesive. In use, theuser would first dispose replaceable thermal subsystem 480 intoreceptacle of main body 430, remove any release paper covering regionshaving adhesive, dispose adhesive band 450 on replaceable thermalsubsystem 480 and main body 430, and place the dual modality system 400on the desired treatment area of a user's body so that durable energysubsystem 420 and replaceable thermal subsystem 480 are coupled to adesired treatment area of a user's body with a flexible web (adhesiveband 450) having an adhesive surface.

In an alternative embodiment use, the user would first disposereplaceable thermal subsystem 480 is affixed to dispose adhesive band450 prior to being disposed into receptacle of main body 430. Dualmodality system 400 is then placed on the desired treatment area of auser's body so that durable energy subsystem 420 and replaceable thermalsubsystem 480 are coupled to a desired treatment area of a user's bodywith a flexible web (adhesive band 450) having an adhesive surface.

Operational details of durable energy subsystem chassis 420 will bediscussed later in this document.

As mentioned earlier, durable energy subsystem chassis (20, 120, 220,320, or 420) are arranged and configured to deliver energy. FIGS. 21 to24 show two detailed embodiments of durable energy subsystem chassis.FIGS. 21 and 22 are top and bottom, respectively, perspective views of afirst embodiment of a durable energy subsystem 600. Durable energysubsystem 600 includes a main body 610 with a first longitudinal end612, a second longitudinal end 614, a first surface 616 and a secondsurface 618. Apertures 620 through main body 610 provide airpermeability and/or skin breathability and light weight to the dualmodality system using energy subsystem 600.

In this embodiment, main body 610 is a printed circuit board (PCB). APCB mechanically supports and electrically connects electroniccomponents using conductive tracks, pads and other features etched fromcopper sheets laminated onto a non-conductive substrate. Components(e.g. capacitors, resistors, controllers, or active devices) aregenerally soldered on the PCB. This embodiment uses an advanced PCBboard in which may of the components are embedded in main body 610substrate. In this embodiment, main body 610 is flexible, so that it canconform to the treatment area of a user's body.

A controller or set of controllers in the durable energy subsystem 600are used to control the energy delivery from durable energy subsystem600 to desired treatment area of a user's body. The energy from the dualmodality system may be delivered continuously, discontinuously, or maybe delivered intermittently.

Embedded in and exposed on first surface 616 of main body 610 are apower source 630, contacts 640, charging module 650 and signalsend/receive unit 660. Embedded in and exposed on second surface 618 ofmain body 610 are a plurality of energy emitters 670. The plurality ofenergy emitters 670 are disposed in an emission region of main body 610having a length and a width, wherein the emission region length andemission region width are both substantially greater than an emissionregion depth. Power source 630 is typically batteries, which in thisembodiment are rechargeable using charging module 650. Durable energysubsystem 600 may optionally include at least one component arranged andconfigured to communicate data through wired or wireless communicationwith external devices, such as a smart phone or other computer orcommunication device connected to a network.

Energy emitters 670 may comprise one or more electromagnetic radiationemitters/modalities. These include, but are not limited to, light,electromagnetic field, microcurrent, electrical stimulation (TENStrans-cutaneous electrical nerve stimulation, MENS, PENS),iontophoresis, sonophoresis (require additional element, topical,active, etc.). In some embodiments, energy emitters 670 may emit lightin the form of visible, ultra-violet (UV), or Infra-Red (IR) light. Inother embodiments, energy emitters 670 may comprise one or more physicalmotion emitters including without limitation ultrasound, vibration, andcombinations thereof.

In first embodiment durable energy subsystem 600 presented here, energyemitters 670 are light-emitting diode (LED) pairs. By pairing the LEDs,LEDs of a variety of wavelengths can be used to delivery light energy tothe same location. In this embodiment, thirty-two pairs of LEDs arepartially embedded in main body 610 of energy subsystem 600. They arearrayed in an 8-by-4 rectangular pattern. In other embodiments, theremay be more or fewer energy emitters 670, and they may be arranged insquare, triangular, or other patterns, or may be randomly arranged inmain body 610. The number of energy emitters 670 in durable energysubsystem 600 could be 1, or 2, or 5, or 10, or 20 or 100 or more.

While the above description references pairs of LEDs, the light emittermay include LEDs as well as incandescent light bulbs, halogen lamps,lasers, fluorescent lamps, plasma lamps, or combinations of the above.

Durable energy subsystem 600 may be designed to deliver a variety ofirradiances (measured in watts/centimeter²), or, preferably, irradiancedoses (measured in Joules/centimeter²). The number and layout of energyemitters 670 will affect the irradiance or irradiance dose of durableenergy subsystem 600. In a preferred embodiment, the light emitterprovides at least about 1 J/cm², more preferably, at least about 5J/cm². A preferred range is between about 5 J/cm² and about 50 J/cm²,more preferably, between about 5 J/cm² and about 20 J/cm², and mostpreferably, between about 5 J/cm² and about 15 J/cm², and even betweenabout 8 J/cm² and about 12 J/cm².

FIGS. 23 and 24 are top and bottom, respectively, perspective views of asecond embodiment of a durable energy subsystem 700. Durable energysubsystem 700 includes a main body 710 with a first longitudinal end712, a second longitudinal end 714, a first surface 716 and a secondsurface 718. Apertures 720 through main body 710 provide airpermeability or skin breathability and light weight to the dual modalitysystem using energy subsystem 700.

Similar to the first embodiment, main body 710 is an advanced printedcircuit board (PCB), where many of the components are embedded in mainbody 710 substrate. In addition, main body 710 is flexible, so that itcan conform to the treatment area of a user's body.

A controller or set of controllers in the durable energy subsystem 700are used to control the energy delivery from durable energy subsystem700 to desired treatment area of a user's body. The energy from the dualmodality system may be delivered continuously, discontinuously, or maybe delivered intermittently. Durable energy subsystem 700 may optionallyinclude at least one component arranged and configured to communicatedata through wired or wireless communication with external devices, suchas a smart phone or other computer or communication device connected toa network.

In this embodiment, the power source 730 on first surface 716 of mainbody 710 are battery enclosures which each include a rechargeablebattery. In this embodiment, the batteries are rechargeable usingcharger clip 735 which is disposed on second longitudinal end 714 ofmain body 710. In this embodiment, the battery enclosures aresubstantially cylindrical.

In this embodiment, energy emitters 770 are light-emitting diode (LED)pairs. As mentioned earlier, pairing the LED allows durable energysubsystem 700 to delivery light energy of different wavelengths to thesame location. In this embodiment, thirty-two pair of LEDs are disposedon second surface 718 of main body 710 of energy subsystem 700. They arearrayed in an 8-by-4 rectangular pattern defining an emission region ofthe main body 710 having a length and a width, wherein the emissionregion length and emission region width are both substantially greaterthan an emission region depth. In other embodiments, there may be moreor fewer energy emitters 770, and they may be arranged in square,triangular, or other patterns, or may be randomly arranged in main body710. The number of energy emitters 770 are in durable energy subsystem700 could be 1, or 2, or 5, or 10, or 20 or 100 or more.

In the above embodiments, durable energy subsystems 600 and 700 areadvanced printed circuit boards (PCBs). In some embodiments, there maybe a desire to protect the PCBs from the outside environment, especiallymoisture, salt, chemicals and temperature changes. For their protection,durable energy subsystems 600 and 700 may be encased in a protective, orconformal, coating material. Conformal coating material is a thinpolymeric film which ‘conforms’ to the contours of a printed circuitboard to protect the board's components. Typically applied at 25-250micrometers it is applied to electronic circuitry to act as protectionagainst moisture, dust, chemicals, and temperature extremes. Conformalcoatings are also “breathable”, allowing trapped moisture in electronicboards to escape while maintaining protection from environmentalcontaminates. However, these coatings are not sealants, and prolongedexposure to vapors will cause transmission and degradation to occur.

Some of the materials which may be used as conformal coatings include,but are not limited to: acrylics, epoxies, polyurethanes, silicones, andfluoropolymers. The coating material can be applied by various methods,from brushing, spraying and dipping.

FIGS. 25 and 26 show an embodiment of a durable energy subsystem 600encased in a protective coating. FIG. 25 is a top perspective view ofencased 800 durable energy subsystem 600, while FIG. 26 is a bottomperspective view of encased 800 durable energy subsystem 600.

The figures show encased 800 durable energy subsystem 600 has a firstlongitudinal end 812, a second longitudinal end 814, a first surface816, a second surface 818, a plurality of apertures 820, raised regions830 and 840 disposed on first surface 816, and raised regions 875disposed on second surface 818.

Located under raised region 830 is power source 630. Charging module 650and signal send/receive unit 660 are located under raised region 840.Energy emitters 670 are located under raised regions 875. In someembodiments, raised regions 875 act as lenses to focus, or scatter theenergy from energy emitters 670. In addition, raised regions 875 act asspacers between encased 800 durable energy subsystem 600 and thetreatment area of a user's body. Durable energy subsystem 600 mayoptionally include at least one component arranged and configured tocommunicate data through wired or wireless communication with externaldevices, such as a smart phone or other computer or communication deviceconnected to a network.

FIGS. 27 to 30 show a sixth embodiment of a dual modality system 500 ofthe present invention. FIG. 27 is an exploded view of dual modalitysystem 500 which has a durable energy subsystem chassis 520, areplaceable thermal subsystem 580, and a flexible web, such as a belt orstrap 550 to attach subsystems 520 and replaceable thermal subsystem 580to the desired treatment area of a user's body. Replaceable thermalsubsystem 580 has a first surface 582, and a second surface 584, and maybe a heat source or a cooling source.

Durable energy subsystem chassis 520 has a first longitudinal end 521, asecond longitudinal end 522, a first surface 523, a second surface 524,and slots 528 located near first and second ends 521, 522. Disposed onfirst surface 523 of durable energy subsystem chassis 520, are powersource/control modules 534 and charging module 536. In some embodiments,durable energy subsystem chassis 520 is flexible.

Belt 550 has a first longitudinal end 551, a second longitudinal end552, a first surface 553, a second surface 554, and slots 558 positionedto align with power source/control modules 534 located on surface 523 ofdurable energy subsystem chassis 520, End tabs 560 are preferablyflexible and are disposed on first longitudinal end 551 and secondlongitudinal end 552 of belt 550. End tabs 560 each have a first surface562, and a second surface 564.

Replaceable thermal subsystem 580 is coupled to the durable energysubsystem chassis 520 and arranged and configured to deliver thermalenergy. FIG. 28 is a top perspective view of dual modality system 500when the system is assembled. FIG. 29 is a cross-sectional view of dualmodality system 500 in the x-z plane of FIG. 28. When assembled,replaceable thermal subsystem 580 is disposed between durable energysubsystem chassis 520 and belt 550 so that second surface 584 ofreplaceable thermal subsystem 580 contacts first surface 523 of chassis520 and first surface 582 of replaceable thermal subsystem 580 contactssecond surface 554 of belt 550. In addition, when dual modality system500 is assembled, end tabs 560 of belt 550 are woven through slots 528of durable energy subsystem chassis 520. Slots 558 of belt 550 arepositioned to allow power source/control modules 534 located on surface523 of durable energy subsystem chassis 520 to pass through them, givingdual modality system 500 additional stability.

Replaceable thermal subsystem 580 is held on durable energy subsystemchassis 520 by any number of means. These include friction fits betweensecond surface 584 of replaceable thermal subsystem 580 and firstsurface 523 of chassis 520 and between first surface 582 of replaceablethermal subsystem 580 and second surface 554 of belt 550. In otherembodiments, an adhesive may be used to hold replaceable thermalsubsystem 580 to belt 550.

In this embodiment, replaceable thermal subsystem 580 is in the shape ofa rectangular prism. In other embodiments, replaceable thermal subsystem580 may be in other three-dimensional shapes.

Energy emitters 570 are shown as disposed in or proximate to secondsurface 524 of durable energy subsystem chassis 520. In otherembodiments, energy emitters 570 may be disposed on the surface ofsecond surface 524 of durable energy subsystem chassis 520. The number,shape and arrangement of energy emitters 570 in replaceable thermalsubsystem 580 will depend on the treatment type, intensity, and areabeing treated.

In use, durable energy subsystem chassis 520 and the replaceable thermalsubsystem 580 comprising dual modality system 500 are coupled to adesired treatment area of a user's body. In this embodiment, adhesivedisposed on second surface 564 of tabs 560 of belt 550 acts as a meansto couple dual modality system 500 to a desired treatment area of auser's body. In use, second surface 524 of durable energy subsystemchassis 520 contacts the desired treatment area of a user's body. Insome embodiments, adhesive may also be disposed on second surface 524 ofdurable energy subsystem chassis 520. Second surface 564 of tabs 560contacts the user's skin.

Though not shown, sixth embodiment dual modality system 500 may alsohave release paper disposed on the regions having adhesive. In use, theuser would first dispose replaceable thermal subsystem 580 onto firstsurface 523 of durable energy subsystem chassis 520. Then user weaves,or laces end tabs 560 of belt 550 through slots 528 of durable energysubsystem chassis 520. In the next step, user removes any release papercovering regions having adhesive, and places the dual modality system500 on the desired treatment area of a user's body so that durableenergy subsystem 520 and replaceable thermal subsystem 580 are coupledto a desired treatment area of a user's body with a flexible web (belt550) having an adhesive surface. Operational details of durable energysubsystem chassis 520 are similar to those previously discussed fordurable energy subsystem chassis (20, 120, 220, 320, and 420).

Although in this embodiment adhesive disposed on second surface 564 oftabs 560 of belt 550 acts as a means to couple dual modality system 500to a desired treatment area of a user's body, there are other possible ameans to couple dual modality system 500 to a desired treatment area ofa user's body. These include a wrap, sleeve, band, mechanicalattachment, belt, laces, and combinations thereof.

FIGS. 31 to 36 show a seventh embodiment of a dual modality system 900of the present invention. FIG. 31 is an exploded view of dual modalitysystem 900 which has a durable energy subsystem chassis 920, areplaceable thermal subsystem 980, a flexible web, such as a belt orstrap 950 to attach subsystems 920 and replaceable thermal subsystem 980to the desired treatment area of a user's body, and clips 990 to attachbelt 950 to durable energy subsystem chassis 920. Replaceable thermalsubsystem 980 has a second surface 984 and may be a heat source or acooling source.

Durable energy subsystem chassis 920 has a first longitudinal end 921, asecond longitudinal end 922, a first surface 923, and a second surface(not shown). Disposed on first surface 923 of durable energy subsystemchassis 920, are power source/control modules 934 and attachment caps926 with detents 928. In this embodiment, the power sources 934 arebatteries located in battery enclosures which are substantiallycylindrical. Durable energy subsystem chassis 920 may optionally includeat least one component arranged and configured to communicate datathrough wired or wireless communication with external devices, such as asmart phone or other computer or communication device connected to anetwork.

Belt 950 has a first longitudinal end 951, a second longitudinal end952, a first surface 953 and a second surface 954. End tabs 960 arepreferably flexible and are disposed on first longitudinal end 951 andsecond longitudinal end 952 of belt 950. End tabs 560 each have a firstsurface 962, and a second surface 964.

Replaceable thermal subsystem 980 is coupled to the durable energysubsystem chassis 920 and arranged and configured to deliver thermalenergy. FIG. 33 is a top perspective view of dual modality system 900when the system is assembled. When assembled, replaceable thermalsubsystem 980 is disposed between durable energy subsystem chassis 920and belt 950 so that second surface 984 of replaceable thermal subsystem980 contacts first surface 923 of chassis 920 and first surface ofreplaceable thermal subsystem 980 contacts second surface 954 of belt950.

FIG. 34 is a top perspective view of clip 990. Clip 990 has a firstsurface 991, a second surface 993, slots 995, and tabs 996. When dualmodality system 900 is assembled, end tabs 960 of belt 950 are woventhrough slots 995 of clips 990. Clips 990 define the means of attachingbelt 950 to the durable energy subsystem chassis 920 in this embodiment.

FIGS. 35 and 36 show how clip 990 is used to attach belt 950 to durableenergy subsystem chassis 920. FIG. 35 is prior to engagement, while andFIG. 36 shows attachment. In FIG. 35, end tabs 960 of belt 950 are shownas woven through slots 995 of clip 990. Clip 990 is then pressed downonto and attachment caps 926. The body of clip 990 is resilient so thatcomponent 990 has a spring-like opening. Finally, tabs 996 of clip 990engage with detents 928 of attachment caps 926 as shown in FIG. 36. Inthis embodiment, clip 990 corresponds to the shape of the batteryenclosure 934.

Replaceable thermal subsystem 980 is held on durable energy subsystemchassis 920 by any number of means. These include friction fits betweensecond surface 984 of replaceable thermal subsystem 980 and firstsurface 923 of chassis 920 and between the first surface of replaceablethermal subsystem 980 and second surface 954 of belt 950. In otherembodiments, an adhesive may be used to hold replaceable thermalsubsystem 980 replaceable thermal subsystem 980 and belt 950.

In this embodiment, replaceable thermal subsystem 980 is in the shape ofa rectangular prism. In other embodiments, replaceable thermal subsystem980 may be in other three-dimensional shapes. Though not shown in thefigures, durable energy subsystem chassis 920 has energy emitters innumber, shape and arrangement as discussed in previous durable energysubsystems in this disclosure. Again, the energy emitters define anemission region of the chassis 920 having a length and a width, whereinthe emission region length and emission region width are bothsubstantially greater than an emission region depth.

In use, durable energy subsystem chassis 920 and the replaceable thermalsubsystem 980 comprising dual modality system 900 are coupled to adesired treatment area of a user's body. In this embodiment, adhesivedisposed on second surface 964 of tabs 960 of belt 950 acts as a meansto couple dual modality system 900 to a desired treatment area of auser's body. In use, the second surface of durable energy subsystemchassis 920 contacts the desired treatment area of a user's body. Insome embodiments, adhesive may also be disposed on the second surface ofdurable energy subsystem chassis 920. Second surface 964 of tabs 960contacts the user's skin.

Though not shown, seventh embodiment dual modality system 900 may alsohave release paper disposed on the regions having adhesive.

In this embodiment, belt 950, replaceable thermal subsystem 980, andclips 990 are shown as preassembled (see FIGS. 31 and 32). In otherembodiments, user would partially, or fully assemble the componentsbefore attaching them to replaceable thermal subsystem 980. In theseembodiments, clips 990 are reusable.

In one embodiment of use, the user would first place replaceable thermalsubsystem 980 onto first surface 923 of durable energy subsystem chassis920. Then user weaves, or laces end tabs 960 of belt 950 through slots995 of clips 990. Next, user attaches belt 950 to durable energysubsystem chassis 920 using clips 990 as discussed above. In the nextstep, user removes any release paper covering regions having adhesive,and places the dual modality system 900 on the desired treatment area ofa user's body, so that durable energy subsystem 920 and replaceablethermal subsystem 980 are coupled to a desired treatment area of auser's body with a flexible web (belt 950) having an adhesive surface.Operational details of durable energy subsystem chassis 920 are similarto those previously discussed for durable energy subsystem chassis (20,120, 220, 320, 420 and 520).

Although in this embodiment adhesive disposed on second surface 964 oftabs 960 of belt 950 acts as a means to couple dual modality system 900to a desired treatment area of a user's body, there are other possible ameans to couple dual modality system 900 to a desired treatment area ofa user's body. These include a wrap, sleeve, band, mechanicalattachment, belt, laces, and combinations thereof.

Replaceable thermal subsystems 80, 180, 280, 380, 480, 580, and 980 arearranged and configured to deliver thermal energy. Replaceable thermalsubsystems may comprise one or more heating or cooling sources in whichcan generate heat or cold by chemical or physical means. For areplaceable thermal subsystem which delivers heat, the replaceablethermal subsystems employ a one-time exothermic chemical reaction. Insome embodiments, heat generation is triggered by unwrapping anair-tight packet containing slightly moist iron powder and salt orcatalysts which oxidizes over a period of hours after being exposed tooxygen in the air. Another type contains separate compartments withinthe replaceable thermal subsystem; when the user squeezes thereplaceable thermal subsystem, a barrier ruptures and the compartmentsmix, producing heat such as the enthalpy change of solution of calciumchloride dissolving.

Phase change materials (PCMs) can also be used for replaceable thermalsubsystem which deliver heat. The heat of fusion is used to release thethermal energy. Heat is released when the material changes from solid toliquid or vice versa.

For a replaceable thermal subsystem which delivers cooling, thereplaceable thermal subsystems employ a one-time endothermic chemicalreaction. In some embodiments, replaceable thermal subsystem consists oftwo bags; one containing water, inside a bag containing ammoniumnitrate, calcium ammonium nitrate or urea. Cold generation is triggeredwhen the inner bag of water is broken by squeezing the package, allowingthe solid to dissolve in the water in an endothermic reaction. Thisreaction absorbs heat from the surroundings, quickly lowering the pack'stemperature.

Phase change materials can also be used for replaceable thermalsubsystem which deliver cooling. The heat of fusion is used to releasethe thermal energy. Cooling occurs when the material changes from solidto liquid or vice versa.

As mentioned in some embodiments, the dual modality systems of thedisclosed invention are coupled to a desired treatment area of a user'sbody using adhesives. In some embodiments, water soluble bioadhesivepolymers can be used for skin adhesive properties. Examples useful forthe invention include, but are not limited to, cellulose and itsderivatives, polyvinyl pyrrolidone, water soluble celluloses, polyvinylalcohol, ethylene maleic anhydride copolymer, methylvinyl ether maleicanhydride copolymer, acrylic acid copolymers, anionic polymers ofmethacrylic acid and methacrylate, cationic polymers withdimethyl-aminoethyl ammonium functional groups, polyethylene oxides,water soluble polyamide or polyester, polyethylene glycol, water solubleacrylic polymers, water soluble polyesters, hydroxyalkyl starches,casein, gelatin, solubilized proteins, polyacrylamide, polyamines,polyquarternium amines, styrene maleic anhydride resins, polyethyleneamines. The water soluble carbohydrate can form hydrogen or covalentbonding to the water soluble or hydrophilic polymer in the film.

In some embodiments, the dual modality system described above may haveone or more sensors to indicate conditions at the treatment area. Theone or more sensors may be disposed on or in either the durable energysubsystem chassis, or the replaceable thermal subsystem. In someembodiments, the one or more sensors may be a thermal sensor. In theseembodiments, the dual modality system may also have an indicator, suchas a display, to report of out-of-range thermal conditions. In apreferred embodiment, the “out-of-range thermal condition” may be set topermit a maximum operating temperature at the skin of about 45° C. Orthe dual modality system may have a controller to shut down the systemor alter elements of the system to maintain the desired conditions atthe treatment area.

While in most of the foregoing embodiments, the replaceable thermalsubsystem 80, 180, 280, 380, 480, 580, and 980 may be in otherthree-dimensional shape, such as, but not limited to: triangular prism,square prism, hexagonal prism, cylinder, cone, partial sphere, partialovoid, irregular solids, and the like. The receptacle is shaped toaccommodate these replaceable thermal subsystems.

Embodiments of the dual modality system of the present invention will beused in the following manner to enhance the effect of treatment to anarea of a user's body. For illustrative purposes, use of sixthembodiment dual modality system 500 will be presented.

In one embodiment, the user first activates replaceable thermalsubsystem 580 and places subsystem 580 onto first surface 523 of durableenergy subsystem chassis 520. Then user weaves, or laces end tabs 560 ofbelt 550 through slots 528 of durable energy subsystem chassis 520. Inthe next step, user removes any release paper covering regions havingadhesive, and places dual modality system 500 on the desired treatmentarea of a user's body. So, areas of contact between dual modality system500 and the treatment area are second surface 524 of durable energysubsystem chassis 520 and second surface 564 of tabs 560. The attachmenthas sufficient attachment strength to prevent separation dual modalitysystem 500 from the treatment area during routine movements of the skin.

In some embodiments, dual modality system 500 is purchased as apre-assembled device with replaceable thermal subsystems 580 attached toor formed on the first surface 523 of durable energy subsystem chassis520. In these embodiments, dual modality system 500 may be viewed as aone-time use treatment device. User activates replaceable thermalsubsystem 580 just prior to placing dual modality system 500 on thedesired treatment area of the user's body. In these embodiments, theremay be release liners disposed on any or all adhesives surfaces forprotection prior to use.

In other embodiments, a user may purchase a kit containing durableenergy subsystem chassis 520 and belt 550, along with one or moreseparately packed replaceable thermal subsystems 580. Kits may containone or more durable energy subsystem chassis 520, as well as one ormore, two or more, five or more, or ten or more, or twenty or morereplaceable thermal subsystems 580. In these embodiments, replaceablethermal subsystems 580 may be packed in air-tight packs to preventinitiation of their thermal reaction. In these embodiments, durableenergy subsystem chassis 520 and belt 550 are both reusable. For eachuse, user activates replaceable thermal subsystem 580 just prior to orafter assembling dual modality system 500, and then places dual modalitysystem 500 on the desired treatment area of the user's body. There maybe release liners disposed on any or all surfaces to protect thesurface(s) prior to use.

In still other embodiments, a user may purchase a kit containing durableenergy subsystem chassis 520 with one or more separately packedreplaceable thermal subsystems 580 and belts 550. Kits may contain oneor more durable energy subsystem chassis 520, as well as one or more,two or more, five or more, or ten or more, or twenty or more replaceablethermal subsystems 580 and belts 550. In these embodiments, replaceablethermal subsystems 580 may be packed in air-tight packs to preventinitiation of their thermal reaction. In these embodiments, durableenergy subsystem chassis 520 is reusable. For each use, user activatesreplaceable thermal subsystem 580 just prior to or after assembling dualmodality system 500, and then places dual modality system 500 on thedesired treatment area of the user's body. There may be release linersdisposed on any or all surfaces to protect the surface(s) prior to use.

In yet other embodiments, kits may contain one or more pre-assembleddual modality system 500, with one or more additional separately packedreplaceable thermal subsystems 580 and belts 550. Kits may contain oneor more, two or more, five or more, or ten or more, or twenty or morereplaceable thermal subsystems 580 and belts 550. In these embodiments,replaceable thermal subsystems 580 may be packed in air-tight packs toprevent initiation of their thermal reaction. In these embodiments,durable energy subsystem chassis 520, and sometimes belts 550, arereusable. For each use, user activates replaceable thermal subsystem 580just prior to placing dual modality system 500 on the desired treatmentarea of the user's body. There may be release liners disposed on any orall surfaces to protect the surface(s) prior to use.

Once dual modality system 500 has been placed on the desired treatmentarea of the user's body, user initiates the durable energy subsystemchassis 520 treatment cycle, energizing the energy emitters 570. Thiscan be accomplished, for example, by the user pressing and on/off switchlocated on durable energy subsystem chassis 520 or, if the dual modalitysystem 500 includes at least one component arranged and configured tocommunicate data through wired or wireless communication with externaldevices, using a smart device such as a cell phone to initiate thetreatment cycle. As mentioned previously, treatment cycles can uselight, heat, cooling, vibration, or combinations thereof. The length ofthe treatment cycle will depend on the treatment being performed. Insome embodiments, durable energy subsystem chassis 520 treatment cycleis less than sixty (60) minutes, or thirty (30) minutes, or ten (10)minutes, or five (5) minutes, or one (1) minute.

The treatment cycle is next completed. In some embodiments, the usermanually completes the cycle by, for example, by the user pressing andon/off switch located on durable energy subsystem chassis 520, or usinga smart device such as a cell phone to initiate the treatment cycle. Inother embodiments, durable energy subsystem chassis 520 has a timingmechanism, and dual modality system 500 will shut down upon completionof the treatment cycle.

Next, dual modality system 500 has been is separated from the treatmentarea.

The durable energy subsystem chassis may be formed by any means known tothose skilled in the art. Materials of construction include polymers andelastomers, including without limitation, thermoplastic elastomers(“TPE”), thermoplastic urethanes (“TPU”), silicones, acrylonitrilebutadiene styrene polymers (“ABS”), among may flexible and more rigidmaterials. Preferably, the materials include sufficient transmissiveproperties to transmit the energy, e.g., light, electromagnetic field,microcurrent, electrical stimulation (TENS trans-cutaneous electricalnerve stimulation, MENS, PENS), iontophoresis, sonophoresis, and/ormotion, e.g., ultrasound and/or vibration to the treatment surface. Inaddition, for embodiments in which the replaceable thermal subsystem isplaced over the emission region of the chassis, good thermalconductivity characteristics are also highly desirable.

While the durable energy subsystem chassis may be printed, cast,injection molded and/or overmolded in a series of steps, the chassis mayalso be made by forming (e.g., by molding) an upper housing and a lowerhousing (independently or as a clam-shell construction), and placing aflexible or semi flexible circuit board between the two housings andadhesively attaching the housings and circuit board (including powersource and controller) together. Other assembly processes may be used,including those known for use in wearable electronics and smarttextiles. For example, it may be helpful to locally modify theflexibility of the substrate and/or housing to mechanically reinforceregions where brittle components are intended to be positioned.

In the embodiments discussed above, the replaceable thermal subsystemshaving a thermal source are arranged and configured to couple thereplaceable thermal subsystem to the chassis comprising a durable energysubsystem in a configuration wherein the thermal source is substantiallysuperposed over the emission region of the chassis. In otherembodiments, the thermal source is partially superposed over theemission regions of the chassis.

The devices described herein deliver phototherapy and thermal therapy,allowing for relief from musculoskeletal pain and other ailments(including injury to bones, joints, muscles, tendons, ligaments, ornerves).

A method of ameliorating pain uses the steps of assembling any of thesystems described above, activating the replaceable thermal subsystem,attaching the system to a desired treatment area of a user's body, andactivating the durable energy subsystem; wherein the replaceable thermalsubsystem delivers thermal energy to the desired treatment area at apredetermined temperature range for at least one (1) minute, or five (5)minutes, or ten (10) minutes, or thirty (30) minutes, or less than orgreater than sixty (60) minutes. The durable energy subsystem deliversenergy from the group consisting of non-visible light electromagneticradiation, visible light radiation, electromagnetic field, microcurrent,electrical stimulation, iontophoresis, sonophoresis and combinationsthereof independently of the thermal energy.

In some embodiments, the thermal energy is at or above human bodytemperature. In other embodiments, the thermal energy is below humanbody temperature. The thermal energy subsystem comprises a phase changematerial, or provides an exothermic chemical reaction.

The durable energy subsystem is arranged and configured to deliverenergy continuously in some embodiments, and discontinuously in otherembodiments. The durable energy subsystem can also deliver pulsed energyin a predetermined pattern in some embodiments. In some embodiments, thepredetermined pattern comprises a plurality of pulse trains separated byvarying intervals of no energy delivery from the durable energysubsystem. As used herein, a pulse train can be a single extendedcontinuous pulse or can be a sequence of individual pulses in apredetermined pattern.

In some embodiments, the durable energy subsystem is arranged andconfigured to deliver light energy from the group consisting of visiblelight and infrared light. The light energy density is greater than about5 Joules/cm², or greater than about 10 Joules/cm².

EXAMPLE

A flex PCB board and 2 rigid PCB boards were fabricated by SunstoneCircuits (Mulino, Oreg.) using PCB123® software. Thirty-two red andthirty-two IR LED's were attached to the flex board, and 2 NiMHbatteries were mounted to the ends of the flex board. Rigid boards forthe Bluetooth module and the charging module were fixed to the ends ofthe flex board.

The Flex-Rigid board assembly with LED's and batteries were then placedin a mold and cast with silicone and cured at room temperature for 24hours. A second casting with silicone was performed after the first curefollowed by another 24-hour cure at room temperature.

A disposable heat pack was created by taking a 55° C. heat pack (50-60°C. range) made from iron powder, carbon, vermiculite, and sodiumchloride and thermally sealed in a PET/PE substrate. An adhesivelaminate comprising a woven backing, acrylic adhesive, and protectivefacing tabs was laser cut to form an adhesive bandage that would be thevehicle to deliver therapy from the heat pack and to attach the lightbandage to a user's body.

What is claimed is:
 1. A method comprising the steps of: a) unwrapping areplaceable thermal subsystem arranged and configured to deliver thermalenergy from packaging material; b) assembling a system comprising: i) adurable energy subsystem arranged and configured to deliver energy; andii) the replaceable thermal subsystem arranged and configured to becoupled to the durable energy subsystem; and c) activating thereplaceable thermal subsystem; d) attaching the system to a desiredtreatment area of a user's body; and e) activating the durable energysubsystem; wherein the replaceable thermal subsystem delivers thermalenergy to the desired treatment area at a predetermined temperaturerange for at least 30 minutes, and the durable energy subsystem deliversenergy from the group consisting of non-visible light electromagneticradiation, visible light radiation, electromagnetic field, microcurrent,electrical stimulation, iontophoresis, sonophoresis and combinationsthereof independently of the thermal energy.
 2. The method of claim 1wherein the thermal energy is at or above human body temperature.
 3. Themethod of claim 1 wherein the thermal energy is below human bodytemperature.
 4. The method of claim 1 wherein the thermal energysubsystem comprises a phase change material.
 5. The method of claim 1wherein the thermal energy subsystem provides an exothermic chemicalreaction.
 6. The method of claim 1 wherein the durable energy subsystemis arranged and configured to deliver energy continuously.
 7. The methodof claim 1 wherein the durable energy subsystem delivers energydiscontinuously.
 8. The method of claim 7 wherein the durable energysubsystem delivers pulsed energy in a predetermined pattern.
 9. Themethod of claim 1 wherein the durable energy subsystem is arranged andconfigured to deliver light energy from the group consisting of visiblelight and infrared light.
 10. The method of claim 9 wherein the lightenergy density is greater than about 5 Joules/cm².
 11. The method ofclaim 10 wherein the light energy density is greater than about 10Joules/cm².
 12. The method of claim 1 wherein the durable energysubsystem communicates data with an external device.
 13. The method ofclaim 1 wherein the steps of the method ameliorate pain.
 14. The methodof claim 1 further comprising the steps of: f) removing the system fromthe desired treatment area of a user's body; g) disassembling the systemby removing a used replaceable thermal subsystem; h) unwrapping anunused replaceable thermal subsystem arranged and configured to deliverthermal energy from packaging material i) re-assembling the system bycoupling the unused replaceable thermal subsystem to the durable energysubsystem; and j) repeating steps c)-e).